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Carpal Tunnel Release in Diabetic Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT01201109
First received: September 13, 2010
Last updated: September 27, 2010
Last verified: September 2010
History of Changes
  Purpose

The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.


Condition
Carpal Tunnel Syndrome
Diabetes
Nerve Entrapment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Five Years Follow-up After Carpal Tunnel Release in Diabetic and Non-diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • Patient self-reported outcome questionnaire [ Time Frame: 5 years after carpal tunnel release ] [ Designated as safety issue: No ]
    Measured by 1). Boston Carpal Tunnel Questionnaire regarding carpal tunnel symptoms and disability. 2). Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) registering health-related quality of life. 3). Cold intolerance on a CISS score


Secondary Outcome Measures:
  • Nerve conduction study and vibrotactile sense [ Time Frame: 5 years after carpal tunnels release ] [ Designated as safety issue: No ]

    Change in Median nerve function by measuring Distal motor latency and antidromic sensory conduction velocity over the carpal tunnel segment.

    Evaluate development of peripheral neuropathy by measure of sural nerve sensory conduction velocity, sural nerve amplitude and peroneal nerve motor conduction velocity.

    Vibrotactile sense of the hand measured at 7 difference frequences from 5 - 500 Hz.



Enrollment: 66
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetics
Diabetic patients operated for carpal tunnel syndrome
Non-diabetics
Non-diabetic patients operated for carpal tunnel syndrome

Detailed Description:

The Follow-up investigation includes:

  1. Clinical examination of sensory and motor function
  2. Generic and disease specific self-administered questionnaires
  3. Nerve conduction study
  4. Vibration threshold testing
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prospective series of matched diabetic and non-diabetic patients who were operated for carapl tunnel syndrome 5 years ago.

Criteria

Inclusion Criteria:

  • diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago.

Exclusion Criteria:

  • previous carpal tunnel release in the hand under study
  • clinical signs of nerve entrapment other than CTS
  • cervical radiculopathy, inflammatory joint disease
  • renal failure
  • thyroid disorders
  • previous wrist fracture on the affected side
  • daily long-term exposure to vibrating tools
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201109

Locations
Sweden
Dept of Hand Surgery, Skåne University Hospital
Malmö, Sweden, SE 205 02
Sponsors and Collaborators
Skane University Hospital
Investigators
Study Chair: Lars Dahlin, Md, PhD
  More Information

No publications provided

Responsible Party: Niels Thomsen, MD, PhD, Dept of Hand Surgery, Skåne University Hospital, Malmö
ClinicalTrials.gov Identifier: NCT01201109     History of Changes
Other Study ID Numbers: 2010/354
Study First Received: September 13, 2010
Last Updated: September 27, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Skane University Hospital:
Carpal tunnel syndrome
Entrapment neuropathies
Diabetes

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Diabetes Mellitus
Nerve Compression Syndromes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013